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Completed

NCT Number: NCT05003557

Prognostic Outcome Score in Functional Neurological Disorders

Monocentric retrospective observational cohort study, using a consecutive series of patients hospitalized for FND from 2012 to 2015 in the neurology department A of the Grenoble Alpes University Hospital. During the discharge staff, an estimation of different prognostic factors had been performed in a consensual way by the medical team for all subjects. It is possible to calculate a score (POS) retrospectively from the data collected during the staff. The following items were evaluated on a Likert scale from 1 to 5: quality of adherence to the diagnosis, presence of a current medical treatment, presence of a similar history, duration of evolution of the disorders presented, ability to verbalize, presence of a social adaptation to the disorders, access to psychiatric care.

The aim of the study will be to study the properties of the calculated score according to the evolution of the patients. The investigators will retrospectively collect information from the medical records. In addition, the evolution of the disorder since the initial hospitalization will be analyzed via a self-evaluation by the subjects and the study of the current medical records.

The investigators will also collect information on the quality of life of the patients in the cohort and their perception of the disease at present.

Using a Clinical Global Impression (CGI-I) scale on FNDstatus, subjects will be classified into two groups by the two principal investigators (Dr. Vercueil, M. Bratanov): the first with a favorable evolution (disappearance of symptoms at the last follow-up, low health care consumption, favorable self-assessment of health status, persistence of symptoms at a low level of disability, satisfactory social and professional integration), and the second with an unfavorable evolution (persistence of symptoms at a disabling level, high health care consumption, unfavorable self-assessment of health status, lack of social and professional integration, multiple medical consultations). The prognostic properties of the POS score will be then studied in order to establish an ROC curve that will allow to classify patients in the two groups.

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Key information

Conditions

Functional Neurological Symptom Disorder Conversion Disorder Mental Disorders Somatoform Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Grenoble Alpes

Grenoble, 38043, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female gender
  • Hospitalization in Neurology Department A from 2012 to 2015 with a final retained diagnosis of NFT
  • POS score at time of hospitalization available

Exclusion criteria

  • Patient under legal protection
  • Inability to complete a self-questionnaire
  • Minor subjects

Treatment and study plan

Questionnaire Administration

Other

3 different questionnaires are going to be administered to each participant,

  • concerning the current health situation
  • the SF 36
  • the IPQ-R questionnaire

Primary outcomes

  1. Clinical evolution according the Clinical Global Impression scale

    Time frame: continuously through study completion, an average of 1 year

    Using a Clinical Global Impression (CGI-I) scale on FNDstatus, subjects will be classified into two groups by the two principal investigators (Dr. Vercueil, M. Bratanov): the first with a favorable evolution (disappearance of symptoms at the last follow-up, low health care consumption, favorable self-assessment of health status, persistence of symptoms at a low level of disability, satisfactory social and professional integration), and the second with an unfavorable evolution (persistence of symptoms at a disabling level, high health care consumption, unfavorable self-assessment of health status, lack of social and professional integration, multiple medical consultations)

Secondary outcomes

  1. Quality of life of each patient

    Time frame: continuously through study completion, an average of 1 year

    using the 36-Item Short Form Survey (SF-36) Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved.All items are scored so that a high score defines a more favorable health state.

  2. Illness perception as reported by each patient

    Time frame: continuously through study completion, an average of 1 year

    Using the Revised Illness Perception Questionnaire(IPQ-R)

    Coding:

    for identity scale yes = 1; no = 0 for other items: strongly disagree =1, disagree =2, neither agree or disagree = 3, agree = 4, strongly agree = 5

    High scores on the identity, timeline, consequences, and cyclical dimensions represent strongly held beliefs about the number of symptoms attributed to the illness, the chronicity of the condition, the negative consequences of the illness, and the cyclical nature of the condition.

    High scores on the personal control, treatment control and coherence dimensions, represent positive beliefs about the controllability of the illness and a personal understanding of the condition.

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

Facteurs Pronostiques Des Troubles Fonctionnels Neurologiques : étude rétrospective et évaluation d'un Score

Acronym: POSiF

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 12, 2021
Registry last updated
Feb 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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